TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	6987	6987
Material Twisted/Bent	2642	2642
Device-Device Incompatibility	1478	1478
Fracture	1178	1178
Material Deformation	858	858
Naturally Worn	728	728
Dull, Blunt	269	269
Material Fragmentation	268	268
Calibration Problem	253	253
Appropriate Term/Code Not Available	241	241
Material Integrity Problem	240	240
Device Operates Differently Than Expected	220	220
Contamination /Decontamination Problem	217	217
Crack	145	145
Entrapment of Device	137	137
Mechanical Jam	130	130
Mechanical Problem	128	128
Bent	107	107
Detachment of Device or Device Component	103	103
Detachment Of Device Component	90	90
Device Contamination with Chemical or Other Material	85	85
Compatibility Problem	73	73
Connection Problem	66	66
Failure To Adhere Or Bond	64	64
Difficult to Remove	54	54
Device Slipped	53	53
Component Missing	52	52
Use of Device Problem	49	49
Fitting Problem	46	46
Peeled/Delaminated	45	45
Unintended Movement	42	42
Adverse Event Without Identified Device or Use Problem	41	41
Loose or Intermittent Connection	35	35
Packaging Problem	35	35
Physical Resistance/Sticking	35	35
Defective Device	31	31
Material Separation	27	32
No Apparent Adverse Event	26	26
Device Stops Intermittently	25	25
Sticking	24	24
Material Distortion	23	23
Failure to Shut Off	21	21
Continuous Firing	20	20
Device Inoperable	20	20
Delivered as Unsterile Product	19	19
Corroded	19	19
Insufficient Information	19	19
Device Or Device Fragments Location Unknown	18	18
Device Damaged Prior to Use	17	17
Scratched Material	17	17

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	6212	6217
No Consequences Or Impact To Patient	3045	3045
No Known Impact Or Consequence To Patient	2963	2963
No Patient Involvement	1437	1437
No Information	548	548
Insufficient Information	491	491
No Code Available	456	456
Foreign Body In Patient	368	368
Device Embedded In Tissue or Plaque	356	356
Not Applicable	192	192
Sedation	53	53
Injury	34	34
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	22	22
Patient Problem/Medical Problem	19	19
Failure of Implant	15	15
Unspecified Tissue Injury	9	9
Blood Loss	9	9
Hemorrhage/Bleeding	6	6
Pain	6	6
Bone Fracture(s)	4	4
Laceration(s)	4	4
Unspecified Infection	4	4
Local Reaction	3	3
Perforation of Vessels	3	3
Spinal Cord Injury	3	3
Perforation	2	2
Exsanguination	2	2
Skull Fracture	2	2
Reaction	2	2
Tissue Damage	2	2
Ossification	1	1
Foreign Body Reaction	1	1
Burn(s)	1	1
Irritation	1	1
Paralysis	1	1
Neck Pain	1	1
Skin Inflammation/ Irritation	1	1
Test Result	1	1
Nerve Damage	1	1
Fall	1	1
Emotional Changes	1	1
Missing Value Reason	1	1
Death	1	1
Dysphagia/ Odynophagia	1	1
Non-union Bone Fracture	1	1
Joint Laxity	1	1
Impaired Healing	1	1
Fracture, Arm	1	1
Erosion	1	1
Infiltration into Tissue	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Aesculap Implant Systems LLC	II	Jul-19-2022
2	Ascension Orthopedics, Inc	II	Jun-26-2009
3	Biomet, Inc.	II	Sep-28-2012
4	Ebi, Llc	II	Jun-17-2014
5	Ebi, Llc	II	Nov-27-2013
6	Ebi, Llc	II	Mar-15-2013
7	Ebi, Llc	II	Dec-17-2012
8	Flower Orthopedics Corporation	II	Jun-01-2021
9	Greatbatch Medical	II	Jun-01-2016
10	Interventional Spine Inc	II	Oct-13-2011
11	Medtronic Sofamor Danek USA Inc	II	Jan-30-2014
12	Medtronic Sofamor Danek USA Inc	II	Sep-14-2013
13	Orthofix, Inc	II	Jun-01-2016
14	SpineFrontier, Inc.	II	Aug-13-2013
15	SpineFrontier, Inc.	II	Aug-08-2013
16	SpineFrontier, Inc.	II	Aug-08-2013
17	SpineFrontier, Inc.	II	Jul-05-2013
18	Synthes (USA) Products LLC	II	May-28-2024
19	Synthes (USA) Products LLC	II	May-23-2018
20	Trilliant Surgical, LLC	II	Jan-10-2020
21	Wright Medical Technology Inc	II	Sep-22-2010
22	Zimmer Biomet, Inc.	II	Jul-04-2019
23	Zimmer Inc.	II	Jul-06-2011